Clinics can’t retract stem cell treatments gone bad

Stem cell facelift comic

Stem cell facelift comicYou can stop taking a pill or an injection treatment, but you can’t stop or retract stem cell treatments if there’s a bad side effect.

Unlike other kinds of medicines, once stem cells have been transplanted into patients, if something goes wrong you cannot stop the ‘treatment’. There’s no retraction possible because transplanted stem cells spread in the body and potentially integrate.

One of the striking things in the commercial stem cell arena in 2016 was the emergence of patient lawsuits against stem cell clinics including two proposed class action suits. These patients, and I count potentially now more than a dozen, allege a variety of harms ranging from tumors to blindness. The reason I mention this is that there appears to be huge potential for harm to patients from unapproved stem cell therapies. I know a lot of patients who would wish they could undo what the stem cell clinic did. It’s just not possible.Stem cell cartoon

Even in an appropriately regulated stem cell trial context, there’s no easy way to undo stem cell transplants. There has been talk for years about suicide genes to be inserted into stem cells to provide “a net” should something go awry with stem cell treatments, but it’s not clear how well these would work and stem cell clinics aren’t interested in that anyway.

The fact that stem cell treatments cannot be retracted to try to help patients who end up in dire straits because of the experimental therapy means there’s even greater reason why proper oversight is needed. Stem cells are not some universal healing clay with miraculous powers that any doc anywhere can pick up and use in patients with all kinds of health problems.

Doctors should receive extensive training in stem cells (no, a weekend golf course seminar on stem cells doesn’t count) and in bioethics, and they should be in contact with the FDA before injecting even one patient. Doctors should also not try to treat patients with stem cells when the patients have maladies outside the doctor’s area of specialty. There’s nothing magic about stem cells that, for instance, suddenly allows a plastic or orthopedic surgeon or dermatologist to ethically and safely treat patients with conditions outside their expertise like neurological or respiratory problems.

Stem cells are not Starbucks coffee or McDonalds hamburgers that can be safely franchised across the country. Patients shouldn’t be treated like drive-thru customers.

What the recent flurry of stem cell lawsuits also illustrate is that some doctors are putting their practices at grave risk and once you screw up with one or a few patients, again you cannot retract the stem cell treatments. You may have permanently hurt the patients. You’re also likely going to end up in court or making a multi-million-dollar settlement that makes your malpractice insurer very unhappy with you. You could end up in the newspaper too and not in a good way.

8 Comments


  1. Unfortunately, the way things are going, I think the malpractice apptormeys will have a greater impact on that field than the FDA. That is sad. They have a much greater tendency to destroy things by driving up malpractice rates than to impose quality measures and science on those things.


  2. Paul, While I agree with everything you said concerning regulation of stem cells, I would hasten to add that the same reasoning could be applied to blood transfusions, bone marrow transplants, elective surgeries, and some organ transplants. Meaning once the deed is done, there is little recourse to undo what leads to dire consequences. These areas are regulated and still bad things happen.


  3. Of course this is true of very many interventions more accepted in the West. If you’ve taken a yearly injectable osteoporosis drug and your thighs start aching strangely or your teeth falling out, there’s no getting that stuff out of you either. If you recognize that you were pressured to receive unnecessary stents that have clogged up or might do so, good luck getting them out. Good luck reversing an ablation or radiation therapy that has gone bad.

    Even if an invasive procedure is reversible, you may not be able to get it reversed unless you can afford to go abroad to pay out of pocket. I have a family member who was coerced to receive an unnecessary pacemaker and had suffered severe complications from its incompetent initial implantation and programming. Could he get an explantation so he could pass a Canadian immigration health exam or just return to lifting weights without risk and fear? Ha – that would mean admitting that there had been error.

    This is not to say that people shouldn’t fear the known and unknown risks of stem cell treatment. This is to say that whenever they are thinking of having anything whatsoever done that they can’t discontinue or reverse at home without a doctor’s permission and assistance, they should independently investigate and think hard about their willingness to tolerate the potential harms and long-term risks.


  4. Paul: You have some very quotable statements in here- clear and concise- great job! I’ll send journalists to this blog if they are looking for good quotes about these issues.

    I want to point out that getting FDA approval would require an assessment of the long-term effects discovered during clinical trials. That’s the point, really, of FDA oversight- it not only helps patients understand the risks, but also is a boon to clinics- if they perform a treatment that is approved by the FDA…and have the necessary skills to be authorized to perform it…then they have cover if there are adverse effects. I would think that that’s a lot better scenario than being sued for unsubstantiated claims or reckless care of patients.


    • Thanks, Jeanne.
      It is true that the stem cell clinics would benefit longer term if they were compliant, but sadly most of them are not interested in the longer term. They want to make big bucks now and my sense is they don’t care about patients primarily. There are just a few of these businesses that collect data and at least try to analyze (usually unfortunately in an uncontrolled manner) whether what they are doing is safe and effective. Paul


  5. I had it done 8 mo. Ago .It has NOT stopped hurting it all . Day and Night it hurts . Now I’m I a weal chair .can not walk or stand Lorene

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